Saturday, July 6, 2013

Time is running out in NY to file a suit: File or not? (Part eight of x) -Plaintiffs opening remarks 2 of 2- a remarkable summary

The Index of Prior posts on this trial  transcript can be found here:

There will be 4 posts on the opening testimony which of course presents the plaintiffs and defense view of the case.    Part 2 of 4 in the opening remarks by the attorneys.
Plaintiffs attorney (part 2 of 2)
This part is one attorney speaking to the jury summarizing his case

May 2007

A conclusion was reached by Depuy that they must increase the articulating surface of the ASR.  The problems:
  • High ions
  • Excessive wear
The case is the grove with the ball rubbing on the groove so metal ions are released.  Also, the surgeons can't get the placement at exactly 45 degree angle due the fact that 50% of the patient's natural anatomy won't allow it. Depuy notifies no one in the US as the product was just released the prior year into the US market.

June 2007

At a presentation by Depuy to surgeons in England, "A Doctor got up and attacked us on serious design flaws" due to  edge ware.

A study was then undertaken by Depuy  on two metal implants and they found that the ASR had 16 xs greater than the metal on Ultamet which was the benchmark...on their own test.

A brochure was released by the marketing department showing that the metals measured 1 C mm and the test actually showed 2.5 xs that amount of metals. 

Depuy changed the test and reran it until they could find a one that could be beat (so says the plaintiff lawyer.)

September of 2007

Depuy has  another engineer  evaluate the ASR and that engineer found " rim loading is a problem....that results in massively increased wear."  No one other than the Depuy marketing and engineering people who were involved with the ASR design were told.

October of 2007

A Surgeon in Australia said   " I was simply appalled by your most recent communication [from depuy to the  surgeons.]  "Bad surgical technique" but no guidance as to what the wrong patient was.  To simply say that sub optimal patient selection and surgical technique have contributed to the premature failure is absurd." " This is a standard technique of companies offsetting responsibility."

Dec of 2007

Depuy released a statement  "Histological reactions have been reported as an apparent response to exposure to a foreign material."  "The actual chemical significance is unknown."

While Depuy did report the above noting that metal ions are released into the body with the implants, what they didn't report:
  • how much ions
  • cup placements and frequency of complaints
Early 2008

Dupuy then published a book to get the 40 degree angle front and center.

Another surgeon who had performed 200 of these hip procedures in Europe than provided some real data to Depuy.  Depuy said " We were given some clinical data which compares metal ion levels between the BHR (competitive offering to Depuy in Europe] and the ASR.  The data shows that under certain circumstance, the ASR is susceptible to extreme ion levels but in the hands of the same surgeon, BHR didn't have the problem.

Depuy concluded :  "The concern is it can seriously affect our business." " We need to discuss at the earliest possible opportunity, as I believe we need to start an ASR upgrade sooner rather than our plans had suggested."  "We need to get rid of the grove." " We need to fix this."

May 2008 (one year after the surgeons began reporting on the problems and Depuy knew they had to fix the problem.)

"We need a cup redesign but in the short term...Manage perceptions."  "Were going to remove the groove."

Depuy noted that out in the field, other reps (competitive reps) are telling surgeons we are making a change.  "We must keep this under total wraps."  [The project to make these changes will now be called internally] "Project Alpha."....  So the marketing department provides a code name to the change in the implant.

August of 2008

A conclusion was reached by Depuy which is  the business case for the redesign could no longer be justified. 

Dec of 2008 ( 1.5 years after Depuy recognized it had to act)

On top of all of this, Depuy knowing what they did about:
  • their own testing
  • elevated ions
  • surgeons complaining in the field
  • aborting the design to address the problems
They took a full page add out in the journal of Bone and Joint surgery that the AASR had a 99.2 survivorship.

Another surgeon wrote [ I believe in response to this ad]  "We have abandoned the ASR cup due to a 15%-20% failure rate.  Its affected my reputation."

1 day later, an orthopedic design surgeon who worked on other hips for Depuy sent a letter to Depuy stating the articulating surface was too small and should be removed from the market.  Further, the top orthopedic surgeon in Ireland noted this was "the tip of the iceburg."  He suspected there were many other patients that would surface with problems.

Sept 2009 (2 years and 4 months after Depuy knew it had to act)

Depuy decided to "stop selling the hip."  [Now that is different of course than recalling the hips. The big question is when do they stop selling the product.]

A discussion ensued at Depuy as to how this would happen based in part on how much business would be lost.  The strategies considered were varied and ranged from waiting 6 months and allowing only certain hip surgeons to use it vs take it off the market entirely for all surgeons and move the current ASR users to Pinnacle.

So, we all know now that they didn't recall the hip until August of 2010 which was 3 years and 3 months after Depuy knew it had to act.


This is pretty bad and assuming the plaintiffs can support all of this diatribe, I would not hesitate to file a suit but next, we hear from the Defense lawyer and the testimony from the participants.  The Judge instructed the jury to make know conclusions based on the opening remarks.  Wait until you hear the evidence.

Depuy seemed to know a lot and did very little based on this overview to inform people of the gravity of the problems.  Also, It took them 3 years and 3 months to remove this thing from the market.

Very interested in seeing the Defense's opening statement which I will comment on in two parts in the next post.

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